ORLANDO — Children and adolescents with irritable bowel syndrome reported significant improvements in symptoms and quality of life with the use of a proprietary probiotic mixture, compared with placebo, in a randomized, double-blind, crossover trial.
Probiotics have shown some efficacy in adults with irritable bowel syndrome (IBS), said Dr. Stefano Guandalini. However, the probiotic Lactobacillus GG has yielded conflicting results in pediatric IBS studies.
Data from a randomized, double-blind trial showed no superiority over placebo for relief of abdominal pain among children with IBS (J. Pediatr. 2005;147:197–201), whereas data from another study demonstrated that a modest increase in treatment success and reduced frequency of pain with the probiotic compared with placebo (Aliment. Pharmacol. Ther. 2007;25:177–84).
Dr. Guandalini presented results of the first pediatric study of VSL#3—a patented preparation of live, freeze-dried lactic acid bacteria (VSL Pharmaceuticals Inc./Sigma-Tau Consumer Products)—at the annual meeting of the American College of Gastroenterology.
A total of 59 children aged 4 years to 18 years (mean, 12.5 years) completed the trial. Researchers recruited the 35 boys and 24 girls from seven pediatric gastroenterology practices in the United States, Italy, and India.
After a 2-week baseline period, the participants were randomized to probiotic treatment or placebo. The treatment group received one sachet of VSL#3, containing 450 billion lyophilized bacteria, once daily (children up to 11 years of age) or twice daily (children aged 12 years to 18 years). The placebo was identical to the probiotic in terms of appearance and taste.
After 6 weeks of treatment and then a 2-week washout period, patients switched to the other group for an additional 6 weeks of the study.
There were “no untoward side effects in any patients,” suggesting that the probiotic is safe to use, said Dr. Guandalini, professor of pediatrics at the University of Chicago and chief of the pediatric gastroenterology, hepatology, and nutrition section at the university's Comer Children's Hospital.
Patients were assessed at baseline and at 2, 4, and 6 weeks of each phase. Children and adolescents who were treated with VSL#3 reported significant improvements in IBS symptoms, the primary end point. At 6 weeks, they improved from a mean of 4.0 at baseline to 2.4 on the SGARC (Subject's Global Assessment of Relief for Children) index. Although there was a placebo effect (scores improved from 4.0 to 3.3), the change from baseline to 6 weeks was not significant.
The probiotic also was associated with significant improvements, compared with placebo, in three out of four secondary outcomes. For example, abdominal pain/discomfort improved significantly from a baseline score of 2.6 to 1.2 at 6 weeks, compared with a nonsignificant change from 2.1 to 1.6 in the placebo group.
However, abdominal bloating/gassiness improved significantly in both groups. The treatment group scores improved from 2.9 to 1.1 after 6 weeks, whereas placebo group scores improved from 2.2 to 1.5.
In addition, there was no significant difference between groups in occurrence of diarrhea or constipation, “although the slope trended in favor of probiotic treatment,” Dr. Guandalini said. Stool pattern score improved from 2.8 to 1.2 with the probiotic and from 2.2 to 1.3 with placebo at 6 weeks.
“VSL#3 may well have a role in alleviating symptoms and improving quality of life in children with IBS, especially in light of the extreme paucity of currently available means of treatment that can be considered safe and effective in children,” Dr. Guandalini said. “We think probiotic mixture VSL#3 was safe and effective in children with IBS.”
'VSL#3 may well have a role in alleviating symptoms and improving quality of life in children with IBS.' DR. GUANDALINI